Status:
COMPLETED
Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
Lead Sponsor:
Universidad Autonoma de San Luis Potosí
Collaborating Sponsors:
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Conditions:
Head Injury
Eligibility:
All Genders
16-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether rosuvastatin could alter the immunological response after head injury by modulating TNF-alpha,IL6,IL-1.
Detailed Description
The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expe...
Eligibility Criteria
Inclusion
- Man or woman \> 16 and \< 60 years old with HI less 24 hours in progression and Glasgow between \< 13
- Acceptance of family to participate (first grade)
Exclusion
- Previous head injury with severe disability
- History of neurological or psychiatric disease with severe disability
- Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone
- Very poor possibilities for survival
- Use of Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters before randomization
- isolated lesions in brain stem
- Allergy to the drug
- Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease
- Management previous in other Hospital
- Pregnancy
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00990028
Start Date
August 1 2009
End Date
August 1 2011
Last Update
October 6 2011
Active Locations (1)
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1
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, Mexico, 78420